By Danny Yarnall
Nancy Childs woke up on March 21, 2019, to upsetting news for her and her husband, Mike. The Alzheimer’s study sponsored by Biogen and Eisai for their drug aducanumab had been pulled. And the rug had been pulled out from under Mike, Nancy, and many other study participants’ feet. This was the first they heard of the study’s closure, and Penn Memory Center staff were racing to reach out to other participants to provide some guidance.
This haphazard system of communication is addressed by PMC Scholar Emily Largent, JD, PhD, RN; and PMC Co-Director Jason Karlawish, MD, in a new paper out in JAMA Neurology. The paper, “Rescuing Research Participants After An Alzheimer’s Trial Stops Early—Sending Out an SOS,” outlines current issues in participant notification following large-scale drug trials closure and identifies ways for all stakeholders to improve going forward.
In a year that featured several major trial closures, participants were battered left and right by disheartening news, often only finding out once the story broke publicly.
“After the Biogen trial closed, a number of participants expressed dissatisfaction with how they learned about the trial closure. We started thinking about how we could do better,” said Dr. Largent.
The logistical challenge of notifying hundreds to thousands of participants is further complicated if the study sponsors are public companies. In the case of Biogen and Eisai, they have legal obligations to shareholders. Afterward, a simple press release can fulfill the requirements for these companies, allowing newsmedia to get a hold of the story before the study sites, research coordinators, and participants.
This hierarchy, while perhaps understandable in a legal framework, can leave participants like the Childs feeling as though they were “left to drown.” Drs. Karlawish and Largent suggest several options that both study sites and sponsors could use to act as life rafts in the event of study closure.
First, participants ought to be made aware of the possibility of study closure during the consent process as well as the company’s legal obligations to shareholders, with an opportunity to opt-in to receive the same press release at the time of the announcement.
“I think we see an important role for study sponsors that’s been underexplored to date. The norm is for study sites to talk with participants – but as we’ve seen, this can leave participants feeling like they’re the last to know,” Dr. Largent said.
Study sites also bear the ethical concerns of the participants. After trial closures, participants lose the support network of the study team that was strengthened over months of visits, often seeing members of the team more often than their own family. This can result in, as Nancy Childs put, “another dimension of loss” and trauma for participants and their caregivers.
Drs. Largent and Karlawish present the need for greater care on behalf of the study site. They suggest that sites should conduct wellness checks with former participants after the study closes, provide additional support to those who benefit, and connect them with available resources.
The authors argued for greater ethical and moral consideration from study sites and study sponsors for the respect given to participants when these life-altering studies close.
Readers can find the full paper in JAMA Neurology.